SAM URETSKY

Trial Lawyers Didn't Block Flu Shots

On Oct. 11, 2004 the Houston Chronicle published a letter from an
irate reader which began "This winter if you or someone you know gets
the flu because they did not get a flu shot, make sure you thank a
trial lawyer for making us dependent on foreign companies for our
vaccines. It is their greed and avarice that made it impossible for
American companies to provide for American needs." The writer then
continues "Next, thank a Democrat for perpetuating the environment
where the right to be compensated for vaccine interaction outweighs
the lives saved."

Perhaps the argument would be stronger if it weren't for the fact
that in 1986, Congress passed the National Childhood Vaccine Injury
Act, which created the Vaccine Injury Compensation Program (VICP).
This act is funded by a surcharge on vaccine doses, paid for by
patients, and covers the cost of injuries due to vaccines. Also, most
of the lawsuits were due to DPT (diphtheria, pertusis, typhus)
vaccine, which was very risky. DPT has essentially been supplanted by
DTaP (diphtheria-tetanus-acellular pertussis) which has a higher
safety margin.

But there's another possible interpretation. The Republican
Party, with its constant railing against taxes, has failed to
indicate what services these taxes pay for. Yes, they pay for the
armed forces and the FBI, but they also pay for the regulatory
agencies that make and enforce rules. The rules include things like
assuring that the air we breath is breathable, the water we drink is
drinkable, and if a store advertises computers on sale, it actually
has computers to sell. We place a lot of faith in these laws and the
regulatory agencies that enforce them. We believe that the FTC, FCC,
FDA, in fact just about anything that begins with F and stops short
of 4 letters, is beyond politics and working in the public
interest.

But the FDA, for all its theoretical good intent, is understaffed
and underfunded. According to Understanding Government, a program of
the School of Communication of American University, "Fewer than 1,100
FDA investigators must inspect about 120,000 domestic establishments,
from mom-and-pop medical device companies in a garage to
multinational food conglomerates and pharmaceutical giants. A lack of
funding and personnel forces the agency to exercise inspectional
triage ..."

Although the FDA is poorly equipped to monitor production of
drugs and biologicals, many of the shortages have been related to
Good Manufacturing Practices (GMP) compliance. That is, even with its
inadequate surveillance, the FDA has found repeated failures by the
manufacturers to follow recognized standards. While some writers have
complained that these violations are simply matters of record
keeping, the current shortage of influenza vaccine is caused by
bacterial contamination of the vaccine supplies at Chiron's plant in
England. That's not a trivial record-keeping problem. Some of the
best-known companies in the industry have been cited for GMP
violations. Abbott, Eli Lilly, Warner Lambert, Wyeth-Ayerst, and
Fujisawa have all entered into consent decrees with the FDA as a
result of breaches of GMP.

Since even limited inspections have turned up significant
defects, including bacterial contamination, it seems clear that
trusting to the good intentions of the vaccine manufacturers isn't
practical. Unfortunately, fear of lawsuits, which has traditionally
served as a back-up system to assure product safety, no longer
constrains the vaccine manufacturers, since the VICP is picking up
the tab. Vaccines are a low profit item for most manufacturers, and
since the inspections are infrequent, and the VICP offers immunity
from lawsuits, they have every inducement to cut corners.

We the people are picking up the tab for this protection against
lawsuits, but since it's a surcharge on the price of the vaccines
rather than a tax, we get to pretend that we're not paying taxes.

Perhaps we could give the money to the FDA so the agency could do
its job properly, enforce Good Manufacturing Practices, and we could
have the sort of consumer protection that we think we're paying for.
Only that would be called a tax; better leave things alone.